BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINITY DELTA / DELTA XL

    MDR report key: 6972887 · Received October 24, 2017

    Report

    Report Number
    1220063-2017-00057
    Event Type
    Death
    Date Received
    October 24, 2017
    Date of Event
    October 18, 2017
    Report Date
    December 15, 2017
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K152407
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 IT WAS CONFIRMED THAT THE SPO2 SENSOR BEING USED WAS NOT A DRAEGER APPROVED SENSOR AND THAT THE SITE WAS NOT USING DRAEGER ACCESSORIES. THE DELTA IFU (PAGE 7) STATES: ONLY THE ITEMS INDICATED ON THE LIST OF ACCESSORIES IN THE ¿ACCESSORIES¿ CHAPTER HAVE BEEN TESTED AND APPROVED TO BE USED WITH THE DEVICE. ACCORDINGLY IT IS STRONGLY RECOMMENDED THAT ONLY THESE ACCESSORIES BE USED IN CONJUNCTION WITH THE SPECIFIC DEVICE. OTHERWISE THE CORRECT FUNCTIONING OF THE DEVICE MAY BE COMPROMISED. ¿

    Additional Manufacturer Narrative · 1

    A PATIENT DEATH WAS REPORTED WHERE THE SPO2 SENSOR WAS DISCONNECTED FROM THE PATIENT AND DID NOT ALARM. DRAEGER REVIEWED THE LOGS WHICH DID NOT AID IN THIS INVESTIGATION. DRAEGER TESTED THE MONITOR AND NON DRAEGER SPO2 SENSOR AND THE REPORTED SYMPTOM COULD NOT BE VERIFIED. NO FAILURE WAS DETECTED. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED. OTHER VITAL PARAMETERS ARE AVAILABLE SUCH AS ECG/NIBP TO MONITOR THE PATIENT AND ARE NOT AFFECTED. NOTE: THAT THE DRAEGER DELTA INSTRUCTIONS FOR USE (IFU) STATES THAT AMBIENT LIGHT CAN INTERFERE WITH PULSE OXIMETRY MEASUREMENTS IF THE SENSOR IS NOT PROPERLY ATTACHED, CAUSING ERRATIC MEASUREMENTS OR MISSING VALUES. OBSERVE PROPER PLACEMENT AND COVER THE SENSOR WITH OPAQUE MATERIAL IF INTERFERENCE DUE TO AMBIENT LIGHT IS SUSPECTED. NOTE THAT THIS CUSTOMER IS USING NON DRAEGER ACCESSORIES. THE IFU PROVIDES THE FOLLOWING WARNING ¿ ONLY THE ITEMS INDICATED ON THE LIST OF ACCESSORIES IN THE ¿APPROVED OPTIONS AND ACCESSORIES¿ CHAPTER HAVE BEEN TESTED AND APPROVED TO BE USED WITH THE DEVICE. ACCORDINGLY IT IS STRONGLY RECOMMENDED THAT ONLY THESE ACCESSORIES BE USED IN CONJUNCTION WITH THE SPECIFIC DEVICE. OTHERWISE THE CORRECT FUNCTIONING OF THE DEVICE MAY BE COMPROMISED. A QUERY OF SIMILAR COMPLAINTS SHOWED THIS IS AN ISOLATED CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017 A PATIENT THAT WAS BEING MONITORED BY TWO PARAMETERS: SPO2 AND PULSE, WAS FOUND DECEASED. THE STAFF INDICATED THERE WAS NO SPO2 ALARM PRIOR TO THE EVENT. ADDITIONALLY, WHEN FOUND, THE SPO2 SENSOR WAS NEXT TO THE PATIENT, HOWEVER SPO2 CONTINUED TO SHOW SATURATION LEVELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017 A PATIENT THAT WAS BEING MONITORED BY TWO PARAMETERS: SPO2 AND PULSE, WAS FOUND DECEASED. THE STAFF INDICATED THERE WAS NO SPO2 ALARM PRIOR TO THE EVENT. ADDITIONALLY, WHEN FOUND, THE SPO2 SENSOR WAS NEXT TO THE PATIENT, HOWEVER SPO2 CONTINUED TO SHOW SATURATION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751485 INFINITY DELTA / DELTA XL PHYSIOLOGICAL MONITORING SYSTEM CBK DRAEGER MEDICAL SYSTEMS, INC MS18597

    Patients

    Seq Age Sex Outcome Treatment
    1 Death